S&amp;m for analyzing and assessing depression and other mood disorders using electoencephalograhic (eeg) measurements

ABSTRACT

This invention is directed to systems and methods for analyzing depression, and more particularly relates to systems and methods for analyzing and assessing depression and mood disorders in an individual using electroencephalographic measurements. Embodiments of the invention are not limited to depression, but can also include other mood disorders such as bipolar disorder and other disorders with at least one genetic-related component.

RELATED APPLICATION

This application claims priority to U.S. Provisional Ser. No.60/741,843, entitled “Systems and Methods for Analyzing and DiagnosingDepression Using Electroencephalographic (EEG) Measurements”, filed Dec.1, 2005.

FIELD OF THE INVENTION

This invention is directed to systems and methods for analyzingdepression, and in particular relates to systems and methods foranalyzing and assessing depression and other mood disorders in anindividual using electroencephalographic measurements.

BACKGROUND OF THE INVENTION

According to United States Health and Human Services (USHHS) 2002 Reporton Mental Health in the United States, approximately 3.7% of children5-17 years old will be diagnosed with depression in a given year. Thatmeans approximately 2.2 million annually for a child/adolescent marketof US$440 million if averaging 1 scan per patient. According to theNational Institute for Mental Health (NIMH), every year 9.5% of thepopulation suffers one or more depressive disorders, with womenexperiencing depression about twice as often as men. In the UnitedStates, this means about 28.1 million annually for a general populationmarket worth about US$5.62 billion if averaging 1 scan per patient.While diagnosis may only require one scan, tracking of treatment mayrequire multiple scans.

Quantitative electroencephalography (qEEG) has been utilized by somehealthcare professionals to analyze and diagnose certainpsychopathological conditions. For instance, literature has reportednearly 100 studies which have examined qEEG in association with emotionsand related psychopathology (See Allen & Kline, 2004; Coan & Allen,2004). In some of these studies, asymmetry between left and rightfrontal qEEG measurements has been observed to be associated withindividuals either demonstrating or being at risk for depressivepsychopathology. One analysis of qEEG measurements for asymmetry can beperformed utilizing a Fast Fourier Transform (FFT) that can provideaveraged results for all epochs accepted after artifacting. At least twostudies have observed greater statistical differences betweenexperimental groups by using an analysis that includes FFT of eachindividual epoch and then determination of a percentage time with leftor right favored asymmetry (See Baehr, Rosenfeld, Baehr, & Earnest,1998; Baehr, Rosenfeld, Miller, & Baehr, 2004).

Quantitative electroencephalography (qEEG) has also been used by otherhealthcare professionals or personnel for other types of monitoring,such as monitoring the effects of anesthesia on a patient. For example,analysis of qEEG measurements using discriminant analysis can provide adiscriminant variable called “cordance.” This type of analysis can alsobe used for investigating brain lesions and characterizing patients withdementia.

Frontal alpha qEEG asymmetry has been commonly used by healthcareprofessionals and researchers to investigate depressive disorders.Conventional techniques utilizing calculation of asymmetry, such assimple arithmetic difference between the power values of the twohemispheres, to identify depression have been used by healthcareprofessionals. One technique, such as neurofeedback, biofeedback orneurotherapy, uses qEEG asymmetry as a marker variable to treatdepression. This technique uses simple subtraction of left and righthemisphere power variables. Other similar techniques examine anarithmetic difference between power values of the frontal regions of theleft and right hemispheres determined using an FFT of all includedepochs averaged in combined sets. There can be substantial variabilityin the power at the frontal sites of each hemisphere. With priortechniques, valuable information from the variability can be lost in theaveraging process, and valuable information from the averaged values canbe diminished when not accounting for the variability. Meta-analysis ofvarious literature using such conventional techniques can produce aneffect size of approximately 0.6, which estimates a classificationaccuracy of about 60%. That is, identification and diagnosis ofdepression using such conventional techniques can be approximately 60%accurate.

One conventional technique uses a discriminant analysis and a clusteranalysis to diagnose depression. This technique can require discriminantanalysis of specific qEEG variables including those of absolute power,relative power, coherence, and asymmetry. However, this technique canalso utilize the qEEG variables in the manner typical for the field asdescribed above, which can lose valuable information from thevariability.

Single recordings of qEEG measurements can be utilized to analyze orinvestigate asymmetry. Some studies have utilized a repeated measuresdesign coupled with a relatively simple method for isolating relativelystable qEEG components. This static-type method involves a basicaveraging technique with the repeated measures, and can lead to improvedprecision in the investigation and analysis of asymmetrical qEEGmeasurements and results. See (Davidson, 1998).

One mathematical technique can separate qEEG measurements intorespective static components and dynamic components. Prior applicationsof this technique have been limited to studies of qEEG and genetics,which demonstrated the effectiveness of this type of analysis indetermining the stable, genetic components of qEEG. When using thistechnique in studies of dizygotic and monozygotic twins as well asimmediate family members and the general population, genetic similaritybetween individuals has been associated with the spectral patternsimilarity of the stable components of the qEEG data (Stassen, Lykken,Propping, & Bomben, 1988).

Therefore, a need exists for systems and methods for analyzing andassessing depression in an individual using electroencephalographicmeasurements. Another need exists for systems and methods for analyzingand assessing mood disorders in an individual usingelectroencephalographic measurements.

Yet another need exists for systems and method for analyzing andassessing bipolar disorder in an individual usingelectroencephalographic measurements.

Yet another need exists for systems and method for analyzing andassessing a disorder with at least one genetic-related component in anindividual using electroencephalographic measurements.

SUMMARY OF THE INVENTION

Systems and processes according to various aspects and embodimentsaccording to the invention address some or all of these issues andcombinations of them. They do so by providing at least one system andmethod for analyzing and assessing depression in an individual usingelectroencephalographic measurements. Embodiments of the invention arenot limited to depression, but can also include other mood disorderssuch as bipolar disorder, and other disorders with at least onegenetic-related component.

Embodiments of the invention can incorporate multiple methods foraccounting for the variability of individual qEEG data sets. Embodimentsof the invention can also incorporate multiple methods for capturinginformation associated with the variability of individual EEG data sets,which can be estimated by meta-analytic methods to be of significantvalue when applying EEG to assessment of mood disorders. Embodiments ofthe invention can retain relatively important information from thevariability of the EEG data that may be otherwise lost, discarded, ornot used by conventional techniques. Asymmetry values can be derivedfrom the static and dynamic qEEG components. For example, staticcomponents (“static spectral asymmetry”) can be applied to assessment ofdepressive individuals. Asymmetry values derived from the dynamiccomponents (“dynamic spectral asymmetry”) can be applied to the trackingof changes in symptomology over time in depressive individuals in thepresence and absence of treatment. Conventional techniques do notdistinguish or otherwise separate the static and dynamic components ofqEEG. Using meta-analytic extrapolation, it is estimated thatembodiments of the invention can generate an effect size of about 2.6for a classification accuracy of approximately 90%. While theapproximate 60% accuracy of prior conventional techniques may not besufficient for use in clinical applications, the approximately 90%accuracy of some embodiments of the invention can meet diagnosticstandards.

One embodiment of the invention is a process that includes collectingrepeated baseline qEEG measures, and analyzing single epochs ofasymmetry from static and dynamic qEEG components based at least in parton a spectral pattern mathematical technique. Spectral patterns can beobtained for each electrode site from the qEEG data sets by artifactremoval, subdivision of epochs, and performance of Fast FourierTransforms on individual epochs. From each set of spectra, variabilityplots can be created in which each set of range and frequency points candefine a feature vector of the spectral pattern. In one example, astatic component of the qEEG data can be calculated as the intersectionof the set of spectral patterns for each electrode. In another example,the dynamic component for a particular single spectral pattern can bedetermined as the remainder of the spectral pattern after the overallstatic component has been removed.

The asymmetry values derived from the static components can be appliedto assessment of individuals with depressive and other related emotionalpsychopathology. The asymmetry values derived from the dynamiccomponents can be applied to the tracking of changes in symptomologyover time with individuals in the presence and absence of treatment.

Embodiments of systems, methods, and apparatus in accordance with theinvention can perform some or all of the following functionality: (1)repeated qEEG measurements and analysis, (2) FFT analysis of individualepochs, (3) separation of static and dynamic qEEG components, (4)calculation of static and dynamic asymmetry variables based in part onat least spectral pattern analysis, and (5) application of static anddynamic variables to disorder risk and disorder tracking, respectively.For example, in one embodiment, a combination of the above functionalityand techniques can be used to analyze and diagnose depression in apatient.

One embodiment of the invention includes a method for analyzing andassessing a mood disorder in a person. The method includes receiving aplurality of electroencephalography data associated with the person.Furthermore, the method includes determining at least one staticcomponent of a portion of the plurality of electroencephalography data.Moreover, the method includes determining static asymmetry in the staticcomponent of the portion of the plurality of electroencephalographydata. Further, the method includes based at least in part on the staticasymmetry in the static component of the portions of plurality ofelectroencephalography data, determining an indication for whether theperson is at risk for the mood disorder.

In one aspect of an embodiment of the invention, the method can includedetermining at least one dynamic component of a portion of the pluralityof electroencephalography data. The method can also include determiningdynamic asymmetry in the dynamic component of the portion of theplurality of electroencephalography data. In addition, the method canalso include based at least in part on the dynamic asymmetry in thedynamic component of the portions of the electroencephalography data,determining an indication for predicting and evaluating a treatmentresponse of the mood disorder.

In another aspect of an embodiment of the invention, the method caninclude wherein determining at least one static component of the portionof the plurality of electroencephalography data comprises determining astatic spectral pattern.

In yet another aspect of an embodiment of the invention, the method caninclude wherein determining dynamic asymmetry in the dynamic componentof the portion of the plurality of the electroencephalography datacomprises determining a dynamic spectral pattern.

In a further aspect of an embodiment of the invention, the method caninclude wherein determining static asymmetry in the static component ofthe portion of the plurality of the electroencephalography datacomprises removing the intersection of a left and right spectral patternfrom an original left and right static spectral pattern.

In yet another aspect of an embodiment of the invention, the method caninclude wherein determining dynamic asymmetry in the dynamic componentof the portion of the plurality of the electroencephalography datacomprises removing the intersection of a left and right dynamic spectralpattern from an original left and right dynamic spectral pattern.

In another aspect of an embodiment of the invention, the method caninclude wherein determining static asymmetry in the static component ofthe portion of the plurality of the electroencephalography data canfurther comprise determining an average of maximum and minimum powers ofa right and left side static component.

In another aspect of an embodiment of the invention, the method caninclude wherein determining dynamic asymmetry in the dynamic componentof the electroencephalography data can further comprise determining anaverage of maximum and minimum powers of a right and left side dynamiccomponent.

In yet another aspect of an embodiment of the invention, the method caninclude wherein the mood disorder comprises at least one of thefollowing: depression, bipolar disorder, or a disorder with at least onegenetic-related component.

Another embodiment includes a method for analyzing and assessing a mooddisorder in person using electroencephalography data. The methodincludes collecting electroencephalography data from the person. Inaddition, the method includes determining a static component associatedwith at least some of the electroencephalography data. Furthermore, themethod includes determining a dynamic component associated with at leastsome of the electroencephalography data. Moreover, the method includesdetermining asymmetry in either the static or the dynamic component.Further, the method includes based at least in part on either theasymmetry in the static component or the dynamic component, evaluating acharacteristic associated with the mood disorder.

In one aspect of an embodiment of the invention, the method can includedetermining a left side spectral pattern. In addition, the method caninclude based at least in part on the electroencephalography data,determining a right side spectral pattern. Furthermore, the method caninclude removing an intersecting portion of the left side spectralpattern and right side spectral pattern to obtain an overall asymmetricspectral pattern.

In another aspect of an embodiment of the invention, the method caninclude wherein determining asymmetry in either the static or thedynamic component further comprises valuating a ratio of theintersecting portion of the left side spectral pattern and right sidespectral pattern with a union of the left side spectral pattern andright side spectral pattern.

In yet another aspect of an embodiment of the invention, the method caninclude wherein determining asymmetry in either the static or thedynamic component comprises implementing a learning-type algorithm todefine one or more weighting factors to ascertain a similarity of eachfrequency band associated with the electroencephalography data.

In yet another aspect of an embodiment of the invention, the method caninclude wherein determining asymmetry in either the static or thedynamic component comprises determining a percent of time the patient'sleft side is favored or disfavored relative to the patient's right side;and comparing the percent of time the patient's left side is favored ordisfavored relative to the patient's right side.

In another aspect of an embodiment of the invention, the method caninclude wherein determining asymmetry in either the static or thedynamic component comprises using at least one vector to derive arespective power for each frontal region; and comparing the respectivepowers for each frontal region.

In a further aspect of an embodiment of the invention, the method caninclude wherein the characteristic can comprise at least one of thefollowing: a risk of having the mood disorder, or a symptom of the mooddisorder.

Another embodiment of the invention includes a method for analyzing andassessing a mood disorder in person using electroencephalography data.The method includes collecting electroencephalography data from theperson. In addition, the method includes determining a static componentassociated with at least some of the electroencephalography data.Furthermore, the method includes determining asymmetry in the staticcomponent. Moreover, the method includes based at least in part on theasymmetry in the static component, evaluating a characteristicassociated with the mood disorder.

Yet another embodiment of the invention includes a method for analyzingand assessing a mood disorder in person using electroencephalographydata. The method includes collecting electroencephalography data fromthe person. In addition, the method includes determining a dynamiccomponent associated with at least some of the electroencephalographydata. Furthermore, the method includes determining asymmetry in thedynamic component. In addition, the method includes based at least inpart on the asymmetry in the dynamic component, evaluating acharacteristic associated with the mood disorder.

Yet another embodiment of the invention includes a system for analyzingand assessing a mood disorder in a person. The system includes a datacollection module and a report generation module. The data collectionmodule is adapted to receive a plurality of electroencephalography dataassociated with the person. The report generation module is adapted todetermine at least one static component of a portion of the plurality ofelectroencephalography data, and further adapted to determine staticasymmetry in the static component of the portion of the plurality ofelectroencephalography data. The report generation module is furtheradapted to output an indication of whether the person is at risk for themood disorder based at least in part on the static asymmetry in thestatic component of the portions of plurality of electroencephalographydata.

In yet another aspect of an embodiment of the invention, the system caninclude wherein the report generation module is further adapted todetermine at least one dynamic component of a portion of the pluralityof electroencephalography data. The report generation module can befurther adapted to determine dynamic asymmetry in the dynamic componentof the portion of the plurality of electroencephalography data. Inaddition, the report generation module can be further adapted to outputan indication of predicting a treatment response of the mood disorderbased at least in part on the dynamic asymmetry in the dynamic componentof the portions of the electroencephalography data. Furthermore, thereport generation module can be further adapted to output an indicationof evaluating a treatment of the mood disorder based at least in part onthe dynamic asymmetry in the dynamic component of the portions of theelectroencephalography data.

Therefore various systems and processes according to various embodimentsof the invention can include:

(1) Systems and methods for analyzing and assessing depression in anindividual using electroencephalographic measurements;

(2) Systems and methods for analyzing and assessing mood disorders in anindividual using electroencephalographic measurements;

(3) Systems and methods for analyzing and assessing bipolar disorder inan individual using electroencephalographic measurements;

(4) Systems and methods for analyzing and assessing a disorder with atleast one genetic-related component in an individual usingelectroencephalographic measurements;

(5) Systems and methods for providing an improved, quantitative, andnon-invasive method for assessing both the state and trait presence ofemotional psychopathologies using qEEG procedures;

(6) Systems and methods for providing a qEEG procedure enablingpractitioners to test for emotional psychopathologies using anon-biased, accurate method; and

(7) Systems and methods for providing a qEEG procedure enablingpractitioners to predict and track therapy response, medicationresponse, and time course of emotional psychopathologies using anon-biased, accurate method.

Other systems and processes according to various embodiments of theinvention will become apparent with respect to the remainder of thisdocument.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flowchart for an example method in accordance with anembodiment of the invention.

FIG. 2 is a flowchart for another example method in accordance with anembodiment of the invention.

FIG. 3 is a flowchart for another example method in accordance with anembodiment of the invention.

FIG. 4 is a flowchart for another example method in accordance with anembodiment of the invention.

FIG. 5 is a flowchart for another example method in accordance with anembodiment of the invention.

FIG. 6 is an example system in accordance with an embodiment of theinvention.

FIG. 7 is an example representation of a report including data analysisresults obtained with an embodiment of the invention.

DETAILED DESCRIPTION

The invention relates to systems and processes for analyzing andassessing depression in an individual using electroencephalographicmeasurements. One embodiment of the invention relates to systems andprocesses for analyzing and assessing depression. Another embodimentrelates to systems and processes for analyzing and assessing mooddisorders. Yet another embodiment relates to systems and processes foranalyzing and assessing bipolar disorder. Yet another embodiment relatesto systems and processes for analyzing and assessing a disorder with atleast one genetic-related component.

Before describing the drawings and examples of embodiments in moredetail, several terms are described below in an effort to clarify theterminology used in this document. Additional and fuller understandingof these terms will be clear upon reading this entire document:

“QEEG DATA”: Any data collected from a patient using devices, orprocesses including, but not limited to, electroencephalography (EEG),and the like.

“INDICATOR”: A characteristic that identifies a particular aspect of ahealthy or pathological condition. An indicator, also known as an“indicator variable,” provides, or otherwise can be combined withresearch or other data to provide, context to a biological measurementand facilitates interpretation of the biological measurement withrespect to a particular condition. Typically, an indicator isresearched, verified, and tested to be a generally reliable, repeatable,or statistically significant characteristic for a particular aspect of acondition.

“HEALTH CONDITION”: A physical or mental condition of a patientincluding, but not limited to, healthy or less than healthy conditions,chronic or acute conditions comprising healthy or less than healthyconditions, one or more disorders, complexes, diseases, infections,birth defects, accident sequella, or pathologically-related problems orafflictions.

“EPOCH”: An arbitrary unit or amount of data in a raw data file, such asan electrophysiological data file, collected over a period of time. Araw data file can be decomposed into a series of epochs. Each epoch cancontain information relating to raw biological activity, such as rawelectrophysiological multichannel activity, of any number of channelsover any period of time.

“ARTIFACT”: Some or all signals or activity in a raw data file, such asa raw electrophysiological data file, which can be considered by expertsor others skilled in the art to be due to the movement of some part of aparticular patient, a subject's body, and/or of any environmental originassociated with a patient or subject. Contributors to an artifact caninclude, but are not limited to, heart electrical activity (EKG), eyemovement (FOG), muscle tension (EMG), and respiration. In someembodiments, artifacts can frequently overlap other physiologicalsignals of interest in either or both the time and frequency domains.

“ARTIFACTING”: A process or method that can be performed by a human, ora set of computer-executable instructions such as a computer program,that involves scanning some or all portions of a particular epochcontaining an artifact, and if an artifact exists, can mark some or allportions of any particular epoch accordingly as “included” or “deleted.”

Embodiments of the invention can be based on the recognition thatindividuals with depression, a mood disorder, or other disorder with atleast one genetic-related component typically have a baseline level ofbehavioral functioning with an intermittent, acute level of behavioralexpression superimposed over the top of the baseline. Embodiments of theinvention can also be based on the recognition that qEEG data ormeasurements can be separated into a baseline set of information withacute qEEG features superimposed over the top of the baseline, in otherwords, static (baseline) and dynamic (superimposed) components of qEEGdata or measurements.

Embodiments of the invention can separate the static and dynamiccomponents of a patient's qEEG data or measurements, and apply thestatic component to identify a baseline presence of a particulardisorder or the risk for a particular disorder. Embodiments of theinvention can use the dynamic qEEG component to track acute levels ofbehavioral expressions of the patient over time, which can haveapplications to, for instance, medication response, therapy response,and time course of a particular disorder.

In one embodiment, at least two sessions of qEEG data measurements canbe obtained from a single patient or subject, which in some instances,translates to more than one clinical visit for the patient or subject.In some embodiments, suitable qEEG data measurements can be obtained inone clinical visit with one session of qEEG data measurements from thepatient or subject. In such embodiments, it may be possible that with alarge enough data set from a single session, the variability of the qEEGdata measurements can be determined using spectral pattern techniquesdescribed herein. In some instances, the suitability of use of qEEG datameasurements from a single session can be verified with the collectionand analysis of repeated measures validation data in a clinical study.

Embodiments of the invention can measure or otherwise determineasymmetry in a set of qEEG data measurements. Asymmetry can be definedas a difference between two sets of data measurements. Asymmetry can bemeasured or otherwise determined using some or all of the followingmethods:

In one method, spectral asymmetry can be calculated from a set of leftand right electrode spectral patterns. For example, the intersectingdata from a left electrode spectral pattern and a right electrodespectral pattern can be removed from each original pattern. Theremaining data from each pattern yields the spectral asymmetry betweenthe two sets of data or patterns. Analysis of similarity betweenspectral patterns can be performed using a ratio of the intersection ofthe sets and the union of the sets. In one embodiment, overallsimilarity can be calculated using a learning-type optimizationalgorithm or another similar technique to define one or more weightingfactors in the summation of the contribution to similarity of eachfrequency band.

In another method, feature vectors can be used in the derivation ofstandard frontal power and asymmetry qEEG values of the static and thedynamic components in the alpha frequency range.

In yet another method, percent time of left and right favored asymmetrycan be calculated using the static and dynamic qEEG componentsseparately.

Using some or all of the methods associated with determining asymmetry,asymmetry values derived from the static components (“static spectralasymmetry”) can be applied to the assessment and diagnosis of depressiveindividuals. The asymmetry values derived from the dynamic components(“dynamic spectral asymmetry”) can be applied to the prediction andtracking of changes in symptomology over time in depressive individualsin the presence and absence of treatment.

One example of a method for analyzing and assessing depression in anindividual using qEEG measurements is described in FIG. 1. The examplemethod 100 is not limited to depression, but can also include other mooddisorders such as bipolar disorder and other disorders with at least onegenetic-related component. The example method 100 can be performed by asystem such as 602 in FIG. 6.

The method 100 shown in FIG. 1 begins at block 102. In block 102, an EEGsignal associated with a subject or patient is received. That is, qEEGdata measurements associated with a subject or patient are received by asystem, such as 602 in FIG. 6. For example, a plurality of electrodesites can be located with respect to a patient's body, such as thepatient's head, using a qEEG data collection device, system, ortechnique and the International 10-20 system of electrode placement. Asuitable system associated with electrodes capable of collecting qEEGdata measurements is described below with respect to FIG. 6. The areason the patient's body, for instance, the patient's head, can be cleanedusing an appropriate qEEG preparation cleaner and alcohol. For example,a patient can be fitted with a stretch Lycra™ cap that can be adjustedso that the proper electrodes sit over the sites located in the stepabove. Once the electrode cap is properly placed, a syringe can be usedto apply conductive gel to the patient's scalp in the selected sites.Each electrode site can then be checked by a healthcare professional orpersonnel to ensure that an accurate qEEG data measurement can beobtained from that site.

In one embodiment, qEEG measurements can be collected both with thesubject's eyes closed and with the subject's eyes opened. For example,qEEG measurements can be collected for approximately 20 minutes with asubject's eyes closed (approximately 630 epochs) and for approximately10 minutes with the subject's eyes opened data (approximately 315epochs).

Block 102 is followed by block 104, in which the qEEG data is digitizedand screened for artifacts. In one embodiment, the qEEG data can bedigitized and screened by a system, such as 602 in FIG. 6, and the qEEGdata can be analyzed to identify artifacts. In one example, affectedepochs of qEEG data can be removed from a particular data set ofinterest. In another embodiment, at least 15 epochs of data, which maybe minimally affected by artifacts, can be collected from a particularsubject with the subject's eyes closed and with the subject's eyes open.In another embodiment, at least 45 epochs of data can be collected froma particular subject with the subject's eyes closed.

Block 104 is followed by block 106, in which epoch subsets areprocessed. For example, once a sufficient number of relativelyartifact-free qEEG data epochs are obtained from a particular patient,one or more subsets of qEEG data can be further processed. In thisembodiment, qEEG data from each included paired electrode sites (forexample, F3 and F4, and CZ as a reference) can be transformed to thefrequency domain on an epoch-by-epoch basis using a Fast FourierTransform (FFT) in blocks 108 and 110 for each respective epoch. Foreach frequency interval (defined by the frequency resolution of thedata), using the data from all the transformed epochs, the technique cantake the overall maximum and overall minimum of the calculated powervalues. As shown in this embodiment, each set of data from thetransformed epochs can be used to create one or more spectral patterns.In other embodiments, fewer or greater numbers of data sets can beprocessed using FFT or other techniques to create one or more spectralpatterns.

Blocks 108 and 110 are followed by block 112, in which based in part onat least the qEEG data, spectral patterns are created. A spectralpattern can be defined as the region contained between a set of maximumand minimum power points, and can be described by feature vectors, onefor each frequency interval, defined for instance, by frequencyinterval, maximum power, and minimum power. The information precedingthe frequency interval can include the patient, trial number, and anyadditional information desired for the data analysis. The methods fordata analysis using spectral patterns can be derived from mathematicalset theory, and some or all applications and subsequent equations can bedefined in related terms.

Furthermore, in this embodiment, when two or more spectral patterns havebeen obtained for a single subject or patient, the static and dynamicportions of the spectral patterns can be separated, for instance, usingthe feature vectors and mathematical set theoretical methods. Each ofthe spectral patterns from the particular patient can be denoted asp(i), where i is an indexing variable for the patterns, numbering from 1to n, and where n is the total number of spectral patterns for thepatient. The static component of the spectral pattern can then bedefined as the intersection of all the obtained spectral patterns, thatis, the area defined by the least of the maximum power values and thegreatest of the minimum power values over all p(i) at each frequencyinterval. In set theoretical notation, this definition is equivalent tos=∩p(i) where s denotes the static component of the EEG data, which isin itself a spectral pattern. The dynamic component of each spectralpattern p(i) can be defined as the difference between that spectralpattern and the static component defined above. Once again, usingset-theoretical notation, this is equivalent to d_(i)=p(i)−s where d_(i)denotes the dynamic component of the i^(th) spectral pattern, p(i) asbefore denotes the i^(th) spectral pattern, and s denotes the staticcomponent as defined above. The static and dynamic components can betreated as individual spectral patterns for the purposes of measuringasymmetry and other types of analysis. In some embodiments, thisparticular method can distinguish between state and trait phenomena inqEEG data.

Block 110 is followed by decision block 112, in which a determination ismade whether another trial or test is available or possible. That is,whether additional qEEG data can be collected from the patient orsubject and processed as needed. If another trial or test is availableor possible, the YES branch can be followed to block 102 and blocks102-110 can be repeated. Therefore, as needed, additional qEEG data canbe collected from the patient or subject. In one embodiment, two or morevisits spaced several days or weeks apart can be performed for arepeated measures analysis of qEEG data for the subject with thesubject's eyes closed. In this instance, the split between the qEEGstatic and dynamic components can be more precise and more easilydistinguishable. In some embodiments, if the subject has a menstrualcycle, qEEG data collection during the luteal phase can be avoided.

Returning to decision block 112, if a determination is made that thereis not another trial or test available or possible, the NO branch isfollowed to block 114. At block 114, the EEG components comprising theqEEG data can be separated and analyzed. In this embodiment, using thespectral patterns from each site as described above, the spectralpatterns can be separated into static and dynamic components. Forexample, qEEG data or measurements can be separated into a baseline setof information with acute qEEG features superimposed over the top of thebaseline, in other words, the qEEG data can be separated between static(baseline) and dynamic (superimposed) components.

As shown in this embodiment, the static and dynamic asymmetry betweenthe patterns can be measured or otherwise determined. For measuring thestatic asymmetry, the branch labeled “STATIC” can be followed from block114 to blocks 116 and 118. For measuring the dynamic asymmetry, thebranch labeled “DYNAMIC” can be followed from block 114 to blocks 120and 122.

In blocks 116 and 120, the static asymmetry and dynamic asymmetry arecalculated or otherwise determined, respectively. For example, for eachspectral pattern (noting again that the static and dynamic componentsare interpreted as separate spectral patterns for this example method)the spectral pattern technique described above can measure or otherwisedetermine asymmetry by intersecting the left and right spectralpatterns, and the intersection can be removed from each original patternfor analysis of the data. In FIG. 7, 700 provides a samplerepresentation of the intersection of right (F4) and left (F3) staticcomponents of spectral patterns. Using set theory notation, asymmetrycan be defined as P′(L)=P(L)−P(L)∩P(R), where P′(L) denotes theasymmetry pattern of the left side, and P(L) and P(R) denote the leftand right spectral patterns, respectively. The same equation with the Land R's reversed can define asymmetry for the right side. These tworesults, which once again are spectral patterns themselves, are thencompared in the alpha frequency band, for instance, the 8-13 Hz range,to measure or otherwise determine the asymmetry.

The spectral pattern technique can allow for a similarity comparisonbetween two or more spectral patterns, for example from different timesand sites from a single individual, or between two individuals within agroup. The similarity coefficient can once again be calculated usingset-theoretical techniques, the notation of which is used herein.Denoting the two patterns m and n, we define the similarity between thepatterns as

${{s^{\prime}\left( {m,n} \right)} = \frac{{m\bigcap n}}{{m\bigcup n}}},$

or the ratio of the intersection of the two patterns to the union of thetwo patterns on a vector-by-vector basis. In other words, this is theratio of the number of area elements the two patterns share to the totalnumber contained in the two. Overall similarity can then be defined as

${s\left( {m,n} \right)} = {\sum\limits_{k}\; {{w(k)}{s_{k}^{\prime}\left( {m,n} \right)}}}$

where the w(k) is a weighting factor for the k^(th) frequency bandsubject to the condition that w(k) sums to 1 over all included k values.Initially, w(k) is proportional to 1/k, but a learning optimizationalgorithm or other similar techniques can adjust this initial weighting.Note the subscript k denotes the restricting of the similarity s′ to thek^(th) frequency band, all bands being weighted and then summed togetherto determine the overall similarity coefficient for the patterns beinganalyzed.

Using the above calculations for spectral components of paired right andleft side electrodes, a respective power for each frontal region can becalculated. The powers can be calculated from each of the static anddynamic feature vectors using the average of the maximum and minimumpowers, and then applied to the standard asymmetry equation (R−L)/(R+L),where R equals right side electrode power and L equals left sideelectrode power. Note that similar equations of asymmetry can be appliedto this technique and that amplitude or power values may be used. Inorder to conform to convention from previous studies, the alpha band canbe defined as the 8-13 Hz range of the transformed data. Note that thealpha range has not been standardized by the healthcare field and avariety of ranges may be used to similar effect.

Epoch by epoch power values of paired right and left side electrodes canbe used to calculate asymmetry for each epoch in the alpha range (8-13Hz). This set of individual asymmetry values can be used to calculate afurther spectral pattern for asymmetry, as described above, producingfeature vectors for the static and dynamic components of asymmetry. Themaximum and minimum values of the feature vectors can be averaged toproduce static and dynamic asymmetry results. In addition, epoch byepoch asymmetry values can be separated into two sets defined by theranges of the static and dynamic feature vectors. The percentage time isthe percentage of the total time in which asymmetry is calculated (on anepoch-by-epoch basis) to be greater than zero, which is calculated forboth the static and dynamic sets of asymmetry values.

In summary, asymmetry in qEEG data can be calculated using some or allof the following techniques:

-   -   1) Spectral asymmetry can be calculated by removing the        intersection of the left and right (F3 and F4) spectral patterns        from each of the original patterns. Analysis of the similarity        of the patterns can be calculated using a ratio of the        intersection of the sets and the union of the sets.    -   2) Feature vectors can be used in the derivation of the standard        frontal power and EEG asymmetry values of the static and the        dynamic components in the alpha frequency band.    -   3) Percent time of left and right favored asymmetry can be        calculated treating the static and dynamic components of the        spectral patterns as individual spectral patterns.

In addition, embodiments of the invention can determine some or all ofthe following indicator variables associated with qEEG data:

-   -   1) “Static spectral asymmetry” by intersection of right and left        side static components.    -   2) “Dynamic spectral asymmetry” by intersection of right and        left side dynamic components.    -   3) “Static power” by average of the maximum and minimum powers        of the right or left side static components.    -   4) “Dynamic power” by average of the maximum and minimum powers        of the right or left side dynamic components.    -   5) Static spectral asymmetry by average of the maximum and        minimum powers of the right and left side static components        applied to (R−L)/(R+L).    -   6) Dynamic spectral asymmetry by average of the maximum and        minimum powers of the right and left side dynamic components        applied to (R−L)/(R+L).    -   7) Static spectral asymmetry by spectral pattern analysis of        asymmetry calculated by (R−L)/(R+L).    -   8) Dynamic spectral asymmetry by spectral pattern analysis of        asymmetry calculated by (R−L)/(R+L).    -   9) Percent time of left and/or right favored asymmetry by ratio        of epochs with asymmetry (R−L)/(R+L) greater than zero.    -   10) “Static percent time” of left and/or right favored asymmetry        by ratio of static epochs with asymmetry (R−L)/(R+L) greater        than zero.    -   11) “Dynamic percent time” of left and/or right favored        asymmetry by ratio of dynamic epochs with asymmetry (R−L)/(R+L)        greater than zero.

Blocks 116 and 120 are followed by blocks 118 and 122, respectively. Inblock 118, a determination of a risk for a disorder, such as depression,can be made. That is, based on the static spectral asymmetry for aparticular set of qEEG data associated with a patient or subject, a riskthat the patient or subject has a particular disorder can be determined.For example, static spectral asymmetry in a particular set of qEEG dataand at least one indicator variable can be analyzed. In otherembodiments, any combination of the above indicator variables or otherqEEG data-related variables can be analyzed. In other embodiments, anycombination of the above indicator variables or other qEEG data-relatedvariables or other clinical data can be analyzed. In any event,asymmetry values derived from static components of qEEG data can beapplied to assessment of an individual with depression or other relatedemotional psychopathology, for instance, determining whether aparticular individual is at risk for depression.

In block 122, a particular disorder and associated treatment can betracked based in part on at least the dynamic spectral asymmetry for aparticular set of qEEG data associated with a patient or subject. Forexample, the asymmetry values derived from dynamic components of qEEGdata can be applied to the tracking of changes in symptomology of anindividual over time in the presence and absence of treatment, forinstance, tracking depression in a particular individual and predicting,evaluating, and determining the effects of any treatment.

Thus, in one embodiment as shown in block 118, the static asymmetryvalues can be compared with one or more previously stored values orother data in one or more databases and/or cutoffs derived from clinicalresearch which can associate the asymmetry values with baseline presenceor statistical risk of depression. In another embodiment as shown inblock 122, the dynamic asymmetry values can be compared with one or morepreviously stored values or other data in one or more databases and/orcutoffs derived from clinical research which can track normalization ofdynamic asymmetry concurrent with the attenuation of depressive symptomswith treatment or therapy.

Blocks 120 and 124 are followed by block 126, in which the method 100ends. Other example methods can include fewer or greater numbers ofelements or steps in accordance with other embodiments of the invention.

Another example of a method for analyzing and assessing depression andother mood disorders in an individual using electroencephalography orqEEG measurements according to an embodiment of the invention is shownin FIG. 2. The method 200 shown can be implemented with a system such as602 in FIG. 6. The example method 200 begins at block 202.

In block 202, a plurality of electroencephalography data associated witha person is received. For example, qEEG data can be received from apatient, such as 614 in FIG. 6, via a client device, such as 618 in FIG.6, or a biological data collector, such as 628 in FIG. 6. Otherembodiments of the invention can collect electroencephalography dataassociated with a person as described above in FIG. 1.

Block 202 is followed by block 204, in which at least one staticcomponent associated with a portion of the plurality ofelectroencephalography data is determined. For example, a staticcomponent of at least some of the qEEG data can be determined by areport generation module such as 608 in FIG. 6, a processor such as 638in FIG. 6, or other processing component associated with the system 602of FIG. 6. Other embodiments of the invention can determine at least onestatic component associated with electroencephalography data asdescribed above in FIG. 1.

Block 204 is followed by block 206, in which static asymmetry in thestatic component of the portion of the plurality ofelectroencephalography data is determined. For example, static asymmetrycan be determined by a report generation module such as 608 in FIG. 6, aprocessor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. Other embodiments of theinvention can determine static asymmetry of electroencephalography dataas described above in FIG. 1.

Block 206 is followed by block 208, in which based at least in part onthe static asymmetry of the portion of plurality ofelectroencephalography data, an indication for whether the person is atrisk for a mood disorder is determined. For example, an indication canbe determined by a report generation module such as 608 in FIG. 6, aprocessor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. By way of further example,depending on how static asymmetry is determined for a particular person,various aspects of the static asymmetry can be utilized to characterizea degree, likelihood, or risk that the particular person has for atleast one mood disorder, such as depression. Other embodiments of theinvention can determine an amount of risk based on the static asymmetryas described above in FIG. 1.

Block 208 is followed by block 210, in which at least one dynamiccomponent of a portion of the plurality of electroencephalographic datais determined. For example, a dynamic component associated with at leastsome of the qEEG data can be determined by a report generation modulesuch as 608 in FIG. 6, a processor such as 638 in FIG. 6, or otherprocessing component associated with the system 602 of FIG. 6. Otherembodiments of the invention can determine at least one dynamiccomponent associated with electroencephalography data as described abovein FIG. 1.

Block 210 is followed by block 212, in which dynamic asymmetry in thedynamic component of the portion of plurality of electroencephalographydata is determined. For example, dynamic asymmetry can be determined bya report generation module such as 608 in FIG. 6, a processor such as638 in FIG. 6, or other processing component associated with the system602 of FIG. 6. Other embodiments of the invention can determine dynamicasymmetry of electroencephalography data as described above in FIG. 1.

Block 212 is followed by block 214, in which based at least in part onthe dynamic asymmetry in the dynamic component of the portion of theelectroencephalography data, an indication for evaluating a treatment ofthe mood disorder is determined. For example, an indication can bedetermined by a report generation module such as 608 in FIG. 6, aprocessor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. By way of further example,depending on how dynamic asymmetry is determined for a particularperson, various aspects of the dynamic asymmetry can be utilized tocharacterize the particular treatment of a mood disorder, such asdepression, of interest. Other embodiments of the invention candetermine an amount of risk based on the static asymmetry as describedabove in FIG. 1.

The method 200 ends at block 214. Other embodiments of methods inaccordance with the invention can have fewer or greater numbers ofelements or steps. In addition, other embodiments can include otherelements or steps in conjunction with the elements or steps of method200.

Another example of a method for analyzing and assessing depression andother mood disorders in an individual using electroencephalography orqEEG measurements according to an embodiment of the invention is shownin FIG. 3. The method 300 shown can be implemented with a system such as602 in FIG. 6. The example method 300 begins at block 302.

In block 302, electroencephalography data associated with a person iscollected. For example, qEEG data can be collected from a patient, suchas 614 in FIG. 6, via a client device, such as 618 in FIG. 6, or abiological data collector, such as 628 in FIG. 6. Other embodiments ofthe invention can collect electroencephalography data associated with aperson as described above in FIG. 1.

Block 302 is followed by block 304, in which a static componentassociated with at least some of the electroencephalography data isdetermined. For example, a static component of at least some of the qEEGdata can be determined by a report generation module such as 608 in FIG.6, a processor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. Other embodiments of theinvention can determine at least one static component associated withelectroencephalography data as described above in FIG. 1.

Block 304 is followed by block 306, in which a dynamic componentassociated with at least some of the electroencephalographic data isdetermined. For example, a dynamic component associated with at leastsome of the qEEG data can be determined by a report generation modulesuch as 608 in FIG. 6, a processor such as 638 in FIG. 6, or otherprocessing component associated with the system 602 of FIG. 6. Otherembodiments of the invention can determine at least one dynamiccomponent associated with electroencephalography data as described abovein FIG. 1.

Block 306 is followed by block 308, in which asymmetry in either thestatic or dynamic component is determined. For example, static ordynamic asymmetry can be determined by a report generation module suchas 608 in FIG. 6, a processor such as 638 in FIG. 6, or other processingcomponent associated with the system 602 of FIG. 6. Other embodiments ofthe invention can determine static or dynamic asymmetry ofelectroencephalography data as described above in FIG. 1.

Block 308 is followed by block 310, in which based at least in part inthe asymmetry of either the static component or dynamic component, acharacteristic associated with a mood disorder is evaluated. Forexample, asymmetry can be analyzed and a characteristic associated witha mood disorder can be evaluated by a report generation module such as608 in FIG. 6, a processor such as 638 in FIG. 6, or other processingcomponent associated with the system 602 of FIG. 6. In some embodimentsof the invention, a characteristic can be an indicator or indicatorvariable associated with a mood disorder, such as depression. In otherembodiments of the invention, a characteristic can be an indication ofwhether a particular person is at risk for a mood disorder, such asdepression. In other embodiments of the invention, a characteristic canbe an indication of or characterization of a particular treatment of amood disorder, such as depression.

The method 300 ends at block 310. Other embodiments of methods inaccordance with the invention can have fewer or greater numbers ofelements or steps. In addition, other embodiments can include otherelements or steps in conjunction with the elements or steps of method300.

Another example of a method for analyzing and assessing depression andother mood disorders in an individual using electroencephalography orqEEG measurements according to an embodiment of the invention is shownin FIG. 4. The method 400 shown can be implemented with a system such as602 in FIG. 6. The example method 400 begins at block 402.

In block 402, electroencephalography data associated with a person iscollected. For example, qEEG data can be collected from a patient, suchas 614 in FIG. 6, via a client device, such as 618 in FIG. 6, or abiological data collector, such as 628 in FIG. 6. Other embodiments ofthe invention can collect electroencephalography data associated with aperson as described above in FIG. 1.

Block 402 is followed by block 404, in which a static componentassociated with at least some of the electroencephalography data isdetermined. For example, a static component of at least some of the qEEGdata can be determined by a report generation module such as 608 in FIG.6, a processor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. Other embodiments of theinvention can determine at least one static component associated withelectroencephalography data as described above in FIG. 1.

Block 404 is followed by block 406, in which asymmetry in the staticcomponent is determined. For example, static asymmetry can be determinedby a report generation module such as 608 in FIG. 6, a processor such as638 in FIG. 6, or other processing component associated with the system602 of FIG. 6. Other embodiments of the invention can determine staticasymmetry of electroencephalography data as described above in FIG. 1.

Block 406 is followed by block 408, in which based at least in part inthe asymmetry of the static component, a characteristic associated witha mood disorder is evaluated. For example, asymmetry can be analyzed anda characteristic associated with a mood disorder can be evaluated by areport generation module such as 608 in FIG. 6, a processor such as 638in FIG. 6, or other processing component associated with the system 602of FIG. 6. In some embodiments of the invention, a characteristic can bean indicator or indicator variable associated with a mood disorder, suchas depression. In other embodiments of the invention, a characteristiccan be an indication of whether a particular person is at risk for amood disorder, such as depression.

The method 400 ends at block 408. Other embodiments of methods inaccordance with the invention can have fewer or greater numbers ofelements or steps. In addition, other embodiments can include otherelements or steps in conjunction with the elements or steps of method400.

Another example of a method for analyzing and assessing depression andother mood disorders in an individual using electroencephalography orgEEG measurements according to an embodiment of the invention is shownin FIG. 5. The method 500 shown can be implemented with a system such as602 in FIG. 6. The example method 500 begins at block 502.

In block 502, electroencephalography data associated with a person iscollected. For example, qEEG data can be collected from a patient, suchas 614 in FIG. 6, via a client device, such as 618 in FIG. 6, or abiological data collector, such as 628 in FIG. 6. Other embodiments ofthe invention can collect electroencephalography data associated with aperson as described above in FIG. 1.

Block 502 is followed by block 504, in which a dynamic componentassociated with at least some of the electroencephalographic data isdetermined. For example, a dynamic component associated with at leastsome of the qEEG data can be determined by a report generation modulesuch as 608 in FIG. 6, a processor such as 638 in FIG. 6, or otherprocessing component associated with the system 602 of FIG. 6. Otherembodiments of the invention can determine at least one dynamiccomponent associated with electroencephalography data as described abovein FIG. 1.

Block 504 is followed by block 506, in which asymmetry in the dynamiccomponent is determined. For example, dynamic asymmetry can bedetermined by a report generation module such as 608 in FIG. 6, aprocessor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. Other embodiments of theinvention can determine dynamic asymmetry of electroencephalography dataas described above in FIG. 1.

Block 506 is followed by block 508, in which based at least in part inthe asymmetry of the dynamic component, a characteristic associated withtreatment of a mood disorder is evaluated. For example, asymmetry can beanalyzed and a characteristic associated with a mood disorder can beevaluated by a report generation module such as 608 in FIG. 6, aprocessor such as 638 in FIG. 6, or other processing componentassociated with the system 602 of FIG. 6. In some embodiments of theinvention, a characteristic can be an indicator or indicator variableassociated with a mood disorder, such as depression. In otherembodiments of the invention, a characteristic can be an indication ofor characterization of a particular treatment of a mood disorder, suchas depression.

The method 500 ends at block 508. Other embodiments of methods inaccordance with the invention can have fewer or greater numbers ofelements or steps. In addition, other embodiments can include otherelements or steps in conjunction with the elements or steps of method500.

The methods disclosed herein are by way of example only, and othermethods in accordance with embodiments of the invention can includeother steps, or fewer or greater numbers of steps than the methodsherein.

An example system in accordance with an embodiment of the invention isshown as 602 in FIG. 6. FIG. 6 illustrates an example environment 600for a system 602 in accordance with various embodiments of theinvention. Using a system 602 illustrated in FIG. 6, some or all of themethods of FIGS. 1-5 can be implemented.

The environment 600 shown includes a network 604 in communication withthe system 602. In turn, the system 602 includes one or more systemmodules 606, 607, 608, 610 that can operate with and in accordance withembodiments of the invention. Each of the system modules 606, 607, 608,610 can communicate with each other through the network 604 or via anassociated network 612 such as a local area network (LAN). For example,the system modules can be a data collection module 606, a frequencyspectrum/reliability module 607, a report generation module 608, and aresearch analysis module 610. The data collection module 606 andfrequency spectrum/reliability module 607 can communicate with thereport generation module 608 via the Internet or a network such as 604,and the research analysis module 610 can communicate with the reportgeneration module 608 via a LAN, such as 612. Other system modules invarious configurations operating in accordance with embodiments of theinvention may exist. The configuration and arrangement of the systemmodules 606, 607, 608, 610 are shown by way of example only, and otherconfigurations and arrangements of system modules can exist inaccordance with other embodiments of the invention.

Each of the system modules 606, 607, 608, 610 can be hosted by one ormore processor-based platforms such as those implemented by Windows 98,Windows NT/2000, LINUX-based and/or UNIX-based operating platforms.Furthermore, each of the system modules 606, 607, 608, 610 can utilizeone or more conventional programming languages such as DB/C, C, C++,UNIX Shell, and Structured Query Language (SQL) to accomplish variousmethods, routines, subroutines, and computer-executable instructions inaccordance with the invention, including system functionality, dataprocessing, and communications between functional components. Each ofthe system modules 606, 607, 608, 610 and their respective functions aredescribed in turn below.

The data collection module 606 is adapted to collect biological datafrom a user such as a patient 614, person, or individual. For example,biological data can include electroencephalography or qEEG data from apatient, such as 614. The data collection module 606 includes one ormore clients 616, 618 and/or remote devices in communication with thenetwork 604 such as the Internet. Typically, each client 616, 618 is aprocessor-based platform such as a personal computer, personal digitalassistant (FDA), tablet, or other stationary or mobile computing-typedevice adapted to communicate with the network 604. Each client 616, 618can include a respective processor 620, 622, memory 624, 626 or datastorage device, biological data collector 628, and transmitter/receiver630. Other components can be utilized with the data collection module606 in accordance with other embodiments of the invention.

The biological data collector 628 communicates with at least one client616, 618 via a transmitter/receiver 630. In the embodiment shown, abiological data collector 628 such as a medical device obtains orotherwise receives biological data in real-time from a user such as apatient 614. The transmitter/receiver 630 transmits the receivedbiological data from the biological data collector 628 or medical deviceto the client 618. In turn, the client 618 may temporarily store thebiological data in memory 626 or otherwise process the data with theprocessor 622, and further transmit the data via the network 604 to thereliability module 607 and/or report generation module 608. In otherembodiments, a biological data collector 628 may locally store andprocess collected data, and communicate the data directly to thereliability module 607 and/or report generation module 608 via thenetwork 604.

For example, a biological data collector 628 can be a medical devicesuch as a Lexicor Digital Cortical Scan quantitativeelectroencephalographic (QEEG) data acquisition unit and Electrocap(collectively referred to as “DCS device”) provided by Lexicor MedicalTechnology, Inc. This type of medical device and associatedconfiguration can be connected to a user or patient's head, and whenactivated, the medical device provides digitized EEG data via aproprietary digital interface and associated software that permits datato be stored locally in a file format such as a Lexicor file format on ahost platform. In alternative embodiments, data can be transmitted inreal-time via other interfaces such as USB to the host platform such asa server. Stored EEG data can be uploaded to an associated server orclient as needed. In other instances, collected or stored data can beburned onto or otherwise stored in a digital format such as a CD-R diskand then transmitted or transferred to an associated server or client.

Note that a Lexicor file format can be a Lexicor raw EEG data fileformat developed by Lexicor Medical Technology, Inc. This particularfile format has a data structure that is adapted to store 24 channels ofdigitized EEG data to facilitate offline data analysis. Although variousEEG storage formats exist, the Lexicor file format can be adapted tohandle these and other data storage formats. For example, the Lexicorfile format has a global header with 64 integers to handle informationsuch as sample rate, gain of the front end DCS amplifiers, softwarerevision, an total number of epochs. Further, the Lexicor file formatcan include one or more epochs or sections of raw data including a 256byte text array to handle comment entries, as well as an array to handleraw digitized EEG data collected by a DCS device during a particularacquisition period for a particular epoch, and a local header containingthe epoch number and status of the particular epoch.

A biological data collector 628 can also include, but is not limited to,blood pressure monitors, weight scales, glucose meters, oximeters,spirometers, coagulation meters, urinalysis devices, hemoglobin devices,thermometers, capnometers, electrocardiograms (EKGs),electroencephalagrams (EEGs), other digital medical devices that canoutput data via a RS-232 port or similar type connection, and otherdevices or methods that provide data associated with a biological orphysiological function. Biological data collected or otherwise receivedfrom a user, patient, or individual can include, but is not limited to,blood pressure, weight, blood component measurements, bodily fluidcomponent measurements, temperature, heart measurements, brainwavemeasurements, and other measurements associated with a biological orphysiological function.

The transmitter/receiver 630 typically facilitates the transfer of databetween the biological data collector 628 and client 618. Thetransmitter/receiver 630 can be a stand alone or built-in device. Thetransmitter/receiver 630 can include, but is not limited to, a RS-232compatible device, a wireless communication device, a wiredcommunications device, or any other device or method adapted tocommunicate biological data.

A user such as a healthcare provider 632 can share or separately utilizea client 616, 618 to interact or communicate with the network 604depending upon the proximity of the client 616, 618 to the patient 614.The healthcare provider 632 and/or patient 614 may receive specificinstructions from the report generation module 608 via the same or arespective client 616, 618. For example, in response to a particularcondition, the report generation module 608 may request that from thehealth care provider 632 that specific biological data be collected fromthe patient 614. Appropriate instructions may be communicated to thehealth care provider 632 via the network 604 to the client 616. Thehealth care provider 632 can then instruct the patient 614 or otherwiseassist the patient 614 in connecting the biological data collector 628or medical device to the patient 614. When activated, the biologicaldata collector 628 or medical device can transmit biological dataassociated with the patient 614 via the network 604 or Internet to thereport generation module 608. As needed, a healthcare provider 632,and/or patient 614, or other user can input demographic data orotherwise provide demographic data via a respective client 616, 618.

The frequency spectrum/reliability module 607 can be adapted to receivebiological data from the data collection module 606, and to process someor all of the biological data to determine one or more reliabilityindexes based in part on at least some or all of the biological data. Inthe embodiment shown, a frequency spectrum/reliability module 607 can bea set of computer-executable instructions such as a software programstored on a server such as 644, or another processor-based platform suchas a client device in communication with a server. The frequencyspectrum/reliability module 607 shown can be integrated with the reportgeneration module 608. In another embodiment, a frequencyspectrum/reliability module 607 can be a separate stand alone modulewith an associated processor such as an apparatus or reliability device.In another embodiment, a frequency spectrum/reliability module 607 canbe an incorporated sub-system module for an associated website andmanagement administration program module, such as 642. As needed,various reports can be generated by a frequency spectrum/reliabilitymodule 607, and provided to a user, such as a health care provider 632.

The report generation module 608 is adapted to receive, store, andprocess the biological data from the patient 614 for subsequentretrieval and analysis. The report generation module 608 is also adaptedto generate one or more data interpretation tools 634 based uponcollected or otherwise received biological data from the patient 614.Further, the report generation module 608 is adapted to generate areport 636 including one or more data interpretation tools to assist auser such as a health care provider 632 in managing and analyzingbiological data. An example data interpretation tool and report aredescribed in greater detail with respect to FIG. 7. In addition, thereport generation module 608 is adapted to operate in conjunction withor otherwise execute an associated website and management applicationprogram module 642.

Typically, the report generation module 608 is a processor-basedplatform such as a server, mainframe computer, personal computer,personal digital assistant (PDA). The report generation module 608includes a processor 638, an archive database 640, and a website andmanagement application program module 642. A separate server 644 to hostan Internet website 646 can be connected between the report generationmodule 608 and the network 604 or Internet; or otherwise be incommunication with the report generation module 608 and data collectionmodule 606 via the network 604 or Internet. Generally, the separateserver 644 is a processor-based platform such as a server or computerthat can execute a website and management application program module642. In any instance, the report generation module 608 communicates withthe data collection module 606 via the network 604 or Internet. Othercomponents can be utilized with the report generation module 608 inaccordance with other embodiments of the invention.

In one embodiment, the report generation module 608 and other modules,such as 606, 607, 610, 642, can include a set of computer-executableinstructions or an associated computer program. The various sets ofcomputer-executable instructions or computer programs can be processedby one or more associated processors, such as 638, or other computerhardware. Those skilled in the art will recognize the variousembodiments for such modules and the implementation of these modules inaccordance with the invention.

The processor 638 can handle biological data and/or demographic datareceived from the data collection module 606, or received via thefrequency spectrum/reliability module 607. The processor 638 and/or thefrequency spectrum/reliability module 607 can store the biological dataand demographic data in the archive database 640 for subsequentretrieval, and/or process the biological data using other data receivedfrom the research analysis module 610. Typically, the processor 638and/or the frequency spectrum/reliability module 607 can analyzebiological data and/or demographic data from the data collection module606 and can remove unwanted artifacts from the data. Relevant biologicaldata and/or demographic data can be stored in the archive database 640or other data storage device until needed. Using one or more indicators648 received from the research analysis module 610 or otherwisegenerated or stored by the system 602, the processor 638 can process thebiological data and/or demographic data to generate one or more datainterpretation tools 634. The processor 638 can generate a report 636including one or more indicators 638 and associated data interpretationtools 634 for transmission via the network 604 to a user such as thehealth care provider 632 and/or patient 614.

Data interpretation tools 634 can add relevant information and contextto biological and/or demographic data in a report 636, such that thedata can be more readily interpreted by a user such as a health careprovider 632 to determine the state of a particular condition with aparticular patient 614. Data interpretation tools 634 typically includepatterns of biological and/or demographic data for normal subjects andsubjects with the condition. The patterns of biological and/ordemographic data can be presented in a report 636 which can includegraphs and text. These patterns are determined from a meta-analysis ofthe body of scientific literature, and analysis of relevant databasesfor normal subjects as well as those with a particular condition andthose with related conditions.

In one embodiment, biological data such as electroencephalography dataor qEEG data can be received or collected by the data collection module606. The data collection module 606 transmits the data to the reportgeneration module 608, and the report generation module can process thedata. For example, a static and a dynamic component of theelectroencephalography data can be determined, and static and dynamicasymmetry in the electroencephalography data can also be determined.Various indicators, characteristics, aspects, and qualities associatedwith the components and asymmetry can be further determined by thereport generation module 608. In one embodiment, one or more indicatorscan be provided by or otherwise obtained from the research analysismodule 610, or other components of the system 602. Methods andalgorithms for determining components, asymmetry, indicators,characteristics, aspects, and qualities in accordance with embodimentsof the invention are disclosed herein with respect to FIGS. 1-5. Usingthe processed data, the report generation module 608 can furthergenerate an output, such as a report shown and described as 700 withrespect to FIG. 7.

The archive database 640 can be a database, memory, or similar type ofdata storage device. The archive database 640 is adapted to storebiological data such as medical images, medical data and measurements,and similar types of information, as well as demographic data aspreviously described. Generally, the archive database 640 can beutilized by the report generation module 608 to store biological dataand demographic data until called upon.

The website and management application program module 642 is typically aset of computer-executable instructions adapted to provide a website 646with at least one functional module to handle data communication betweenthe website 646 and at least one user such as a health care provider 632and/or patient 614. The website and management application programmodule 642 can be hosted by the report generation module 608, separateserver, and/or a storage device in communication with the network 604. Awebsite and management application program module 642 can include, butis not limited to, a main login module, a patient management module, apatient qualification module, a patient assessment module, a patientcare plan module, a data analysis module, a filter module, animport/export module, a virtual private network electronic datainterchange (VPI EDI) module, a reporting module, an indicator reportnotification module, an indicator report delivery module, anadministrative module, a notification (data filter/smart agent)administration module, a database module, and other similar component orfunctional modules. Other component modules associated with the websiteand management application program module 642 can operate in accordancewith other embodiments of the invention.

The separate server 644 is adapted to host the website 646 viewable viathe Internet with a browser application program. Alternatively, theseparate server 644 may host a website and management applicationprogram module 642 as well. A website 646 provides communication accessfor a health care provider 632 and/or patient 614 to the reportgeneration module 608. For example, a report 636 generated by the reportgeneration module 608 may be posted to the website 646 for selectiveaccess and viewing via the network 604 or Internet by a user such as ahealth care provider 632 and/or patient 614 operating the same or arespective client 616, 618 via the network 604. In other instances, areport 636 may be transmitted by the report generation module 608 to auser such as a health care provider 632 and/or patient 614 via anelectronic mail message communication, a telecommunications device,messaging system or device, or similar type communication device ormethod. An example of a report generated in accordance with variousembodiments of the invention is illustrated and described in detailbelow in FIG. 7.

The associated network 612 is typically a local area network (LAN) thatprovides communications between the report generation module 608 and theresearch analysis module 610. A LAN repository 650 may be connected orotherwise accessible to the associated network 612 for additionalstorage of biological data, indicators, or other data collected,generated, or otherwise received by the system 602.

The research analysis module 610 is adapted to obtain and collectrelevant research materials and data. Furthermore, the research analysismodule 610 is adapted to process relevant research materials and data,and can be further adapted to determine one or more indicators 648 for aparticular condition. Moreover, in one embodiment, the research analysismodule 610 is adapted to provide indicators 648 to the report generationmodule 608 in response to a particular patient's condition or collectedbiological and demographic data. Typically, the research analysis module610 is a processor-based platform such as a server, mainframe computer,personal computer, or personal digital assistant (PDA). The researchanalysis module 610 includes a processor 652, analytical tools 654, anin-house research database 656, a public research database 658, and anormative database 660. Other components can be utilized with theresearch analysis module 610 in accordance with the invention.

The processor 652 handles research and data collected or otherwisereceived by the research analysis module 610. The processor 652 indexesand/or stores the research or data in an associated database forsubsequent retrieval, or processes the research and data using one ormore analytical tools 654. One or more indicators 648 can be provided orotherwise derived by or from the analytical tools 654, and the processor652 can transmit any indicators 648 to the report generation module 608as needed.

At least one analytical tool 654 is utilized by the research analysismodule 610. Typically, an analytical tool 654 is an algorithm thatutilizes research and data to determine one or more indicators 648 for aparticular condition.

The in-house research database 656 can be a collection of research andarticles provided by a particular or third-party vendor. Typically, anentity operating the system 602 can provide its own research andarticles for a range of conditions. For example, information availablefrom an in-house research database includes, but is not limited to,electronic databases, scientific and research journals, on-line sources,libraries, standard textbooks and reference books, and on-line andprinted statements of committees and boards, and the like.

The public research database 658 can be a collection of research andarticles provided by one or more third-parties. Typically, research andarticles are available for free or upon payment of a fee from a varietyof on-line or otherwise accessible sources. For example, informationavailable from a public research database 3656 includes, but is notlimited to, electronic databases, scientific and research journals,on-line sources, libraries, standard textbooks and reference books,on-line and printed statements of committees and boards, and the like.

The normative database 660 can be a collection of electronic databases,scientific and research journals, on-line sources, libraries, standardtextbooks and reference books, on-line and printed statements ofcommittees and boards, and the like.

Another example system to collect and analyze qEEG measurements foranalyzing and assessing depression in an individual will be implementedby Lexicor Medical Technology, Inc. of Augusta, Ga. Other suitablesystems and components to collect qEEG measurements have been disclosedin U.S. Ser. No. 11/053,627, entitled “Associated Systems and MethodsFor Managing Biological Data and Providing Data Interpretation Tools,”filed Feb. 8, 2005, which is a continuation-in-part of U.S. Ser. No.10/368,295, entitled “Systems and Methods For Managing Biological Dataand Providing Data Interpretation Tools,” filed Feb. 18, 2003, whichclaims priority to U.S. Provisional Patent Application No. 60/358,477,filed Feb. 19, 2002, wherein the contents of these applications areincorporated herein by reference. Other system embodiments in variousconfigurations and including other components operating in accordancewith the invention may exist.

In one embodiment, a data collection module, such as 606 in FIG. 6, canreceive qEEG data as described above in FIGS. 1-6. The data collectionmodule can operate in conjunction with a report generation module, suchas 608 in FIG. 6, to process the qEEG data in accordance with some orall of the methods, processes, procedures, and techniques describedabove. The report generation module 608 can include associated reportingand communication functionality to provide electronic and/or printedreport formats to a variety of healthcare professionals, researchers, orother users. In one embodiment, various report formats can be providedvia a network, such as the Internet or network 604 in FIG. 6.

FIG. 7 illustrates an example representation of a report including dataanalysis results obtained using an embodiment of the invention. Thereport 700 can include data, such as text or a graph 702. In thisexample, electroencephalography data has been processed by a reportgeneration module, such as 608 in FIG. 6. The report generation module608 can determine static components of the electroencephalography data.The report generation module 608 can determine the intersection of thespectral patterns for left and right static components of the data. Asshown in FIG. 7, the report generation module 608 can generate, output,or otherwise graphically depict or illustrate the intersection of thespectral patterns for left and right (F3 and F4) static components ofthe data. The intersection of the left and right (F3 and F4) staticcomponents is represented by the data 704 shown in the graph 702. Thegraph 702 includes a plot of frequency in Hertz on the x-axis 706 versuspower in μV units on the y-axis 708. The report generation module 608can plot the data 704 for the intersection of the two static componentsas shown in the graph 702. Using the intersection of the two sets ofdata 704, the report generation module 608 can determine a staticasymmetry for the electroencephalography data. Based at least in part onthe static asymmetry, the report generation module 608 or a user canfurther evaluate or otherwise determine a risk that the patient orsubject has a particular disorder. Based at least in part on the staticasymmetry, the report generation module 608 or a user can implementanalytical tools 654 such as a learning-type algorithm to define one ormore weighting factors to ascertain an indicator 648 such as a patient'ssimilarity and/or risk relative to values in a database 656, 658, 660 ofindividuals in the presence or absence of a particular disorder orcondition.

Other embodiments of a suitable report can include other types of data,text, and graphs. For instance, various indicators, characteristics,aspects, and qualities associated with components, asymmetry, andbiological data such as electroencephalography data can be included in areport generated by a report generation module such as 608 in FIG. 6.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the invention,but merely as exemplifications of the disclosed embodiments. Thoseskilled in the art will envision many other possible variations that arewithin the scope of the invention as defined by the claims appendedhereto.

1-22. (canceled)
 22. A computer operable method for analyzing andassessing a mood disorder in a person, comprising: receiving, in thecomputer, electroencephalography data associated with the person, theelectroencephalography data including at least one static componentcorresponding to a baseline level of behavioral functioning of theperson and including at least one dynamic component corresponding to anacute level of behavioral expression of the person; determining, byoperation of the computer, the static component of a portion of theelectroencephalography data, wherein the static component is independentof the dynamic component included in the electroencephalography data;determining, by operation of the computer, the dynamic component of theelectroencephalography data, wherein the dynamic component isindependent of the static component included in theelectroencephalography data; determining, by operation of the computer,a static asymmetry in the static component, wherein the static asymmetryis determined by computing an intersection between a left spectralpattern of the static component and a right spectral pattern of thestatic component and by removing the intersection from the left andright spectral patterns of the static component; and determining, byoperation of the computer, a dynamic asymmetry in the dynamic component,wherein the dynamic asymmetry is determined by computing an intersectionbetween a left spectral pattern of the dynamic component and a rightspectral pattern of the dynamic component and by removing theintersection from the left and right spectral patterns of the dynamiccomponent; and based at least in part on the static asymmetry in thestatic component and the dynamic asymmetry in the dynamic component,determining, by operation of the computer, an indication for whether theperson is at risk for the mood disorder, wherein the mood disordercomprises at least one of the following: depression, bipolar disorder,or a disorder with at least one genetic-related component.
 23. Themethod of claim 22, further comprising: based at least in part on thedynamic asymmetry in the dynamic component, determining, by operation ofthe computer, an indication for predicting and evaluating a treatmentresponse of the mood disorder, receiving, in the computer, a pluralityof data sets associated with the person, wherein the plurality of datasets comprises electroencephalography data for the person collectedpre-treatment and comprises electroencephalography data for the personcollected post-treatment.
 24. A computer operable method for analyzingand assessing a mood disorder in person using electroencephalographydata, comprising: collecting, in the computer, electroencephalographydata from the person, the electroencephalography data including at leastone static component corresponding to a baseline level of behavioralfunctioning of the person and including at least one dynamic componentcorresponding to an acute level of behavioral expression of the person;determining, by operation of the computer, the static componentassociated with a portion of the electroencephalography data, whereinthe static component is independent of the dynamic component included inthe electroencephalography data; determining, by operation of thecomputer, the dynamic component of the portion of theelectroencephalography data wherein the dynamic component is independentof the static component included in the electroencephalography data;determining, by operation of the computer, a static asymmetry in thestatic component and a dynamic asymmetry in the dynamic component,wherein a static asymmetry is determined by computing an intersectionbetween a left spectral pattern of the static component and a rightspectral pattern of the static component and by removing theintersection from the left and right spectral patterns of the staticcomponent, wherein a dynamic asymmetry is determined by computing anintersection between a left spectral pattern of the dynamic componentand a right spectral pattern of the dynamic component and by removingthe intersection from the left and right spectral patterns of thedynamic component; based at least in part on the static asymmetry in thestatic component and the dynamic asymmetry in the dynamic component,evaluating, by operation of the computer, a characteristic associatedwith the mood disorder, wherein the characteristic comprises at leastone of the following: a risk of having the mood disorder, or a symptomof the mood disorder.
 25. A system for analyzing and assessing a mooddisorder in a person, comprising: a data collection module adapted to:receive electroencephalography data associated with the person, theelectroencephalography data including at least one static componentcorresponding to a baseline level of behavioral functioning of theperson and including at least one dynamic component corresponding to anacute level of behavioral expression of the person; a report generationmodule adapted to: determine the static component of a portion of theplurality of data sets, wherein the static component is independent ofthe dynamic component included in the plurality of data sets; determinethe dynamic component of the portion, wherein the dynamic component isindependent of the static component included in the plurality of datasets; determine static asymmetry in the static component, wherein thestatic asymmetry is determined by computing an intersection between aleft spectral pattern of the static component and a right spectralpattern of the static component and by removing the intersection fromthe left and right spectral patterns of the static component; anddetermine dynamic asymmetry in the dynamic component, wherein thedynamic asymmetry is determined by computing an intersection between aleft spectral pattern of the dynamic component and a right spectralpattern of the dynamic component and by removing the intersection fromthe left and right spectral patterns of the dynamic component; and basedat least in part on the static asymmetry in the static component and thedynamic asymmetry in the dynamic component, output an indication ofwhether the person is at risk for the mood disorder, wherein the mooddisorder comprises at least one of the following: depression, bipolardisorder, or a disorder with at least one genetic-related component. 26.The system of claim 25, wherein the report generation module is furtheradapted to: based at least in part on the dynamic asymmetry in thedynamic component, output an indication of predicting a treatmentresponse of the mood disorder; and based at least in part on the dynamicasymmetry in the dynamic component, output an indication of evaluating atreatment response of the mood disorder, receiving, in the computer, aplurality of data sets associated with the person, wherein the pluralityof data sets comprises electroencephalography data for the personcollected pre-treatment and comprises electroencephalography data forthe person collected post-treatment.
 27. A system for analyzing andassessing a mood disorder in a person, comprising: a data collectionmodule adapted to: receive electroencephalography data associated withthe person, electroencephalography data including at least one staticcomponent corresponding to a baseline level of behavioral functioning ofthe person and including at least one dynamic component corresponding toan acute level of behavioral expression of the person; a reportgeneration module adapted to: determine the static component of aportion of the plurality of data sets, wherein the static component isindependent of the dynamic component included in the plurality of datasets; determine the dynamic component of the portion, wherein thedynamic component is independent of the static component included in theplurality of data sets; determine static asymmetry in the staticcomponent, wherein the static asymmetry is determined by computing anintersection between a left spectral pattern of the static component anda right spectral pattern of the static component and by removing theintersection from the left and right spectral patterns of the staticcomponent; determine dynamic asymmetry in the dynamic component, whereinthe dynamic asymmetry is determined by computing an intersection betweena left spectral pattern of the dynamic component and a right spectralpattern of the dynamic component and by removing the intersection fromthe left and right spectral patterns of the dynamic component; and basedat least in part on the static asymmetry in the static component and thedynamic asymmetry in the dynamic component, output an indication of acharacteristic of the mood disorder, wherein the characteristiccomprises at least one of the following: a risk of having the mooddisorder, or a symptom of the mood disorder.